Ready to start or develop your career in Quality and Regulatory Affairs?
Sterisets Manufacturing, part of the Sterisets International Group, is reinforcing its team and is looking for a QA & RA Techniciam to join our team in Portugal – Penafiel.
With more than 30 years of experience and operations in the Netherlands and Portugal, Sterisets develops and manufactures medical devices that are distributed to customers in more than 60 countries worldwide. As part of our continued growth and organisational development, we are looking for a professional who is motivated to contribute to a dynamic, international and continuously improving industrial environment.
Role Overview
We are looking for a Quality Assurance & Regulatory Affairs Technician to join our team and support Quality and Regulatory activities, contributing to the maintenance of our Quality Management System (QMS) and ensuring compliance with applicable regulations.
This role offers a hands-on opportunity to gain experience in a regulated environment, with exposure to quality processes, complaints handling, and regulatory documentation.
What will you be doing?
- Handle customer and supplier complaints, ensuring proper follow-up, documentation, and alignment with internal procedures;
- Handle investigation activities related to complaints, including data collection and coordination with relevant departments;
- Assist in the preparation and maintenance of Technical Documentation (e.g. risk management, PMS, vigilance)
- Support regulatory submissions and related documentation processes
- Review and update SOPs and quality documentation under supervision
- Support the monitoring and reporting of quality KPIs
- Participate in internal and external audits, supporting preparation and follow-up activities
- Collaborate with different departments to ensure alignment on quality-related topics
- Support the planning and implementation of quality and regulatory activities
Who are we looking for?
- Degree in Pharmacy, Biology, Chemical Engineering, or similar scientific field
- At least 1 year of experience in Quality Assurance and/or Regulatory Affairs;
- Working knowledge of ISO 13485 and MDR is an advantage;
- English level minimum B2 (written and spoken);
- Strong attention to detail and willingness to learn;
- Good communication skills and ability to work cross-functionally
- Proactive attitude and motivation to develop within QA/RA
What we offer?
- Opportunity to join a growing international medical device company
- A collaborative and supportive team environment
- Professional growth and development opportunities
- Direct involvement in the strategic planning and implementation of quality and regulatory activities.
- Fresh fruit and a selection of hot beverages available daily in the workplace.
Notes:
- Sterisets is a European company with operations in the Netherlands and Portugal, therefore internal communication is conducted in English
- To stay closely connected to our operations and collaborate effectively with colleagues, this role is performed primarily on-site, in Penafiel. Structural home working is therefore not part of this position
Application:
Please note that only CVs submitted in English will be considered.
You can apply directly through our website or send your application to hrm.pt@sterisets.com
Sterisets is committed to equal opportunities and equal pay for equal work. Recruitment and selection decisions are based on qualifications, experience and business needs, regardless of gender or any other protected characteristic, in line with European legislation on pay transparency and equal treatment.